The article is devoted to the analysis of the concept of human biosafety during medical procedures using high medical technologies in the field of transplantation of human organs and (or) tissues. An analysis of the regulatory framework in the field of ensuring human biological safety during medical procedures in the field of transplantation and donation is provided, which demonstrates that the biosafety of patients in the Russian Federation is ensured by providing recipients with high-quality biomaterial as strictly established by the legislator based on the achievements of modern medical science. The legislation establishes medical restrictions for potential donors in order to ensure the biological safety of recipients. Special requirements have also been established for medical personnel who have the right to carry out medical procedures related to the transplantation of human organs and tissues. The domestic legislator is actively implementing the concept of biological safety in the field of VMT use by establishing certain criteria and restrictions for this type of assistance, which ensures citizens the right to receive qualified, high-quality medical care in the field of transplantation and donation of human organs and (or) tissues.